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OpenTrials
Completed

NCT Number: NCT06585553

Atrophic Gastritis and OLGIM Stage

Three clinical research coordinators recruited patients aged 40-75 who underwent screening endoscopy at the Digestive Endoscopy Center of Qilu Hospital from July 1, 2022, to July 30, 2024. All participating patients provided written informed consent. Baseline information such as height, weight, age, sex, smoking and alcohol consumption status, HP status, and family history of gastrointestinal tumors were recorded before endoscopy. During endoscopy, the endoscopist observed and photographed the lesser and greater curvature of the antrum, corpus, and incisura, performed the Kimura-Takemoto classification, and classified those with a Kimura-Takemoto score of C0 as non-atrophic gastritis and those with C1-O3 as atrophic gastritis. Patients with atrophic gastritis received free multiple-site biopsies for pathological assessment, including targeted biopsies of suspected IM areas and random biopsies from Sydney classification sites. At least four biopsies were taken from the lesser and greater curvature of the antrum and corpus for pathological evaluation, and OLGIM staging was calculated based on the results.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital

Jinan, Shandong, 250012, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

were patients aged 40-75 undergoing painless screening endoscopy

Exclusion criteria

  • previous gastric surgery; 2) inability to undergo biopsy due to anticoagulant use; 3) refusal to sign informed consent; 4) history of radiotherapy or chemotherapy; 5) new diagnosis of advanced gastric cancer during endoscopy; 6) failure to complete multiple-site biopsy for atrophic gastritis; and 7) diagnosis of non-atrophic gastritis during endoscopy.

Treatment and study plan

Primary outcomes

  1. Diagnostic Performance of IM at Different Sites

    Time frame: 3 years

    Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of IM at different gastric sites for predicting OLGIM stage III/IV were calculated.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Patients with Intestinal Metaplasia in the Lesser Curvature of the Gastric Corpus Require OLGIM Staging: a Secondary Analysis of a Prospective Cohort

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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